Ralston Group recalls Maximum Pelvic Trainers (MPT) due to FDA misbranding and lack of 510(k) submission. Affected units include specific lot numbers listed in the recall notice.
The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.
Ralston Group is recalling their Maximum Pelvic Trainer (MPT) devices because they were incorrectly listed with the FDA and the company did not submit the required 510(k) approval. This means the product is considered misbranded and adulterated if sold.
The device was misbranded and adulterated because it was incorrectly listed with the FDA and the manufacturer did not submit the necessary 510(k) approval. This regulatory failure means the product does not meet FDA safety standards.
Owners of Maximum Pelvic Trainers (MPT) with the listed lot numbers are affected. Individuals using these devices for pelvic health support may be at risk due to regulatory issues.
Check your Maximum Pelvic Trainer (MPT) for the lot numbers listed: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005.
Look for the lot number on your Maximum Pelvic Trainer (MPT) to see if it matches the listed numbers.
The device was incorrectly listed with the FDA and the manufacturer did not submit a 510(k) for approval, making it misbranded and adulterated.
Check the lot number on your device against the list provided in the recall notice to see if it is affected.
The recall does not include a fix or remedy; affected units must be checked against the lot numbers.
We’ve drafted a message you can send Ralston Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2087-2019 — Ralston Group Ralston Group Hello, I own a Ralston Group that is covered by recall Z-2087-2019 from Ralston Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
